Molecular Imaging Directed, 3D Ultrasound-guided, Biopsy System

描述（由申请人提供）：前列腺癌影响美国六分之一的男性。45岁以上的男性都有患前列腺癌的风险。系统经直肠超声（TRUS）引导下的活检是明确诊断前列腺癌的标准方法。每年进行的前列腺活组织检查超过120万次，医疗费用每年超过20亿美元。然而，该技术的采样误差较大，灵敏度较低（39-52%）。这种“盲”活检方法可能漏诊30%的前列腺癌。由于活检呈阴性并不能排除遗漏癌症的可能性，医生和患者在做出治疗决定时都面临着挑战。由于越来越多的年轻男性患有潜在的早期和可治愈的前列腺癌，为了提高癌症的检出率，必须解决这个问题。在我们NIH/ nci支持的埃默里分子和转化成像中心，正电子发射断层扫描（PET）与一种新的分子成像示踪剂FACBC在人类前列腺癌检测中显示出非常有希望的结果。我们假设FACBC PET分子图像可以结合到超声引导下的活检中，以改善癌症的检测。提出的研究是开发一种分子图像定向，三维超声引导系统，用于前列腺的靶向活检。具体目标1：改进实时、机械辅助、3D超声引导设备。与传统的二维图像引导相比，前列腺的三维图像将用于指导活检。具体目标2：开发基于可变形和统计外观模型的前列腺三维超声图像快速分割方法。统计形状模型将从我们的数据库中开发出来，并将用于指导前列腺的自动分割。特异性目的3：将FACBC分子图像与3D超声相结合进行靶向活检。为了解决基于互信息的图像配准的主要局限性，提出了基于联合显著性映射和模糊点对应的可变形图像配准方法。具体目标4：在幽灵和动物中测试集成活检系统的准确性。完整的活检系统也将在少数人类患者中进行测试。我们的FACBC患者研究得到了nih赞助的成像中心项目（P50CA128301）和II期临床试验（NCT00562315）的支持。机械辅助设备已获得FDA 510K批准。拟议的研究将促进学术-工业合作（埃默里大学、西安大略大学罗伯茨研究所和加州格拉斯谷的艾根公司）。如果完全开发，多模态分子图像引导系统不仅可以用于活检，还可以用于近距离治疗、射频热消融、冷冻治疗和光动力治疗。

DESCRIPTION (provided by applicant): Prostate cancer affects 1 in 6 men in the USA. Every man over the age of 45 is at risk for prostate cancer. Systematic transrectal ultrasound (TRUS)-guided biopsy is the standard method for a definitive diagnosis of prostate cancer. More than 1.2 million prostate biopsies are performed annually and the medical cost is more than two billion dollars each year. However, this technique has a significant sampling error and is characterized by low sensitivity (39-52%). This "blind" biopsy approach can miss 30% of prostate cancers. As a negative biopsy does not preclude the possibility of a missed cancer, both the physicians and patients face challenges in making treatment decisions. Due to the increasing number of younger men with potentially early and curable prostate cancer, this problem must be addressed in order to improve cancer detection rate. At our NIH/NCI-supported Emory Molecular and Translational Imaging Center, positron emission tomography (PET) with a new molecular imaging tracer FACBC has shown very promising results for prostate cancer detection in human patients. We hypothesize that FACBC PET molecular images can be incorporated into ultrasound-guided biopsy for improved cancer detection. The proposed research is to develop a molecular image-directed, 3D ultrasound-guided system for targeted biopsy of the prostate. Specific Aim 1: To modify a real-time, mechanically assisted, 3D ultrasound-guided device. Compared to conventional 2D image guidance, 3D images of the prostate will be used to guide the biopsy. Specific Aim 2: To develop fast deformable and statistical appearance model based segmentation methods for 3D ultrasound images of the prostate. Statistical shape models will be developed from our database and will be used to guide automatic segmentation of the prostate. Specific Aim 3: To combine FACBC molecular images with 3D ultrasound for targeted biopsy. New deformable image registration methods based joint saliency map and fuzzy point correspondence will be developed in order to solve major limitations of mutual information based image registration. Specific Aim 4: To test the accuracy of the integrated biopsy system in phantoms and animals. The complete biopsy system will also be tested in a small number of human patients. Our FACBC patient studies are supported by the NIH-sponsored imaging center program (P50CA128301) and by the Phase II Clinical Trial (NCT00562315). The mechanically assisted device has received the FDA 510K approval. The proposed study will promote the academic-industrial collaboration (Emory University, Robarts Research Institute of the University of Western Ontario, and Eigen Inc., Grass Valley, CA). If completely developed, the multimodality molecular image-guided system will be able to be used not only for biopsy but also for brachytherapy, radiofrequency thermal ablation, cryotherapy, and photodynamic therapy.